The present invention relates to a device and a method for aiding urination and eliminating the discomfort and muscular strain associated therewith. In particular, the device and method relate to the introduction into a urinary bladder of a ferromagnetic tubular insert that can be magnetically manipulated into a constricted urethral opening communicating with the bladder, to allow for normal voiding of urine through the opening. The constricted urethral opening is typically caused by an enlarged prostate.
Elderly men are known to suffer from urinary micturitions due to prostate enlargement. This hyperplasia can cause modifications in the anatomy of the bladder neck area, thus changing the pressures on the bladder neck during urination. During normal urination, the external sphincter is opened, while the bladder is contracted and the bladder neck is relaxed, the resultant cross sectional view thereof resembling the shape of a funnel.
In an anomalous condition that is sometimes termed xe2x80x9cbladder neck obstructionxe2x80x9d, the bladder neck is incapable of relaxing and opening while the bladder is contracted. Typically, patients suffering from bladder neck obstruction are elderly men. In the case of a relatively large prostate, the obstruction often occurs not only at the bladder neck, but in the prostatic urethra as well. With smaller prostates (less than 30 grams), however, the obstruction often occurs only in the vicinity of the bladder neck. The funnel shape of the bladder neck is deformed by the prostate.
The situation is exacerbated by the counterproductive effect wherein the increase of the inwardly radial pressure of the surrounding muscles on the bladder further acts to close the bladder neck. The more pressure the muscles surrounding the bladder exert on the bladder, the more the opening to the urinary duct of the bladder (also known as xe2x80x9cbladder neckxe2x80x9d) is contracted, thus constricting the flow of urine therethrough. In FIG. 1, it can be seen that due to the enlarged prostate gland 10, the muscles around the neck 40 of the bladder 20 do not contract towards the center of the bladder, but rather contract towards each other (as shown by arrows 70), thereby closing off the urinary tract. Thus, an increased pressure exerted by the muscles of the bladder wall 21 actually results in an increased pressure on the neck 40 of bladder 20, thereby inhibiting or complicating the flow of urine from bladder 20 through the urethra 90.
Current treatments for bladder neck obstruction include TURP (Trans-Urethral Resection of the Prostate) surgery as well as radical prostatectomy, open surgery, catheterization, urethral stents, and ablation procedures.
For patients who are suffering from bladder neck obstructions a trans-urethral incision prostatectomy is most commonly used. Following the delicate surgery, the patient further requires lengthy outpatient care, and an extensive repertoire of medications addressing post-surgical inflammation, modulating kidney urinary production, modulating hormonal and physical aspects of the prostate, and, additionally, rectal injections of sclerotizing fluid to ameliorate the effects of the surgical trauma and the subsequent swelling from adversely affecting the proctologic profile of the patient.
Post surgery patients are likely to suffer from retrograde ejaculation, incontinence, irritations when passing urine, infection, and a long recovery time and other typical post surgery phenomena that are particularly common in elderly people.
Catheterizations are used in many patients, many of whom have pre-existing medical conditions that preclude a surgical procedure. A catheter is inserted into the urethra and guided into the bladder, and subsequently a balloon is inflated to anchor in place the distal tip of the catheter.
The most commonly known catheter is a Foley catheter, which has a flexible distal tip for easy insertion and a balloon of 10 to 30 cubic centimeters in volume. A catheter of this type demands frequent insertion and extraction, further exacerbating urethral irritation and causing the patient to have additional and undesired urges to urinate. In addition to being cumbersome, if installed within the urinary duct for 24 hours or more, the risk of eminent bacterial infection is extremely high.
Ablation procedures involve the use of ablation catheters. These devices are of complicated construction, typically consisting of a helical electrode located at the distal end of the catheter. An electrode located at the distal end of the device is used to apply RF (radio frequency) electrical current or an electromagnetic energy to surrounding tissues. Although the ablation procedure is generally successful in burrowing open any obstructions and widening the urinary duct, it unavoidably creates sufficient trauma and post-procedural aftereffects to warrant a post operation-like care program for the patient. Additional side effects include inflammation, rectal disorders, a lengthy healing period, and an even more prolonged period in which the patient may be forced to pass an extraneous and abraded epithelial lining within the urine. The passing of a foreign body in the urinary tract causes a continuous and discomforting sensation to the patient.
Other approaches to aiding urination disorders involve urethral stents. Urethral stents are tubular devices, made of metal or plastic, which are inserted into the prostatic urethra. Typically, the tubes consist of 2 sections connected by a short thread. Each of these sections is positioned at a different side of the external sphincter, thus anchoring the stent in place. The stent behaves as a mechanical support to keep the prostatic urethra and the bladder neck wide open (see Yachia D and Beyar M., xe2x80x9cTemporarily Implanted Urethral Coil Stent For The Treatment Of Recurrent Urethral Stricturesxe2x80x9d, J. Urology 1991, Vol. 146, pp. 1001-1004, which is hereby incorporated by reference for all purposes, as if fully set forth herein).
Urethral stents are rarely used as a long-term solution, due to high rate of complications, side effects and discomfort for the patients. These morbidity issues include calcification and the growth of stones, repeated infections, and discomfort due to the existence of a foreign body. Removing a urethral stent from a patient is usually an involved procedure that includes surgery, since the stent can become embedded in the surrounding tissue after a short period of time. Moreover, the use of a urethral stent as a long-term solution for a particular patient usually indicates the lack of a satisfactory long-term solution for that patient.
There is therefore a recognized need for, and it would be highly advantageous to have a non-destructive, sterile device for, and method of, overcoming bladder neck and prostate obstruction, such that substantially normal, natural urination can be achieved.
According to the teachings of the present invention there is provided a device for modulating a passage of urine through a urinary tract of a human body, the device including: (a) a catheter having a first end, and (b) a ferromagnetic element operatively connected to the catheter, wherein the catheter is designed and configured such that when the device is disposed within the body, a magnetic force applied to the ferromagnetic element causes the first end to be wedged into the urinary tract.
According to further features in the described preferred embodiments, the second end of the catheter is disposed in a urinary bladder.
According to still further features in the described preferred embodiments, the device is completely disposed within the body.
According to still further features in the described preferred embodiments, the device further includes: (c) a balloon functionally connected to a second end of the catheter.
According to still further features in the described preferred embodiments, the balloon is designed and configured to be disposed in a urinary bladder.
According to still further features in the described preferred embodiments, the first end of the catheter has a tip.
According to still further features in the described preferred embodiments, the tip has a shape selected from the group consisting of pointed, conic, and bullet type of shape.
According to still further features in the described preferred embodiments, the tip is made of a flexible material.
According to still further features in the described preferred embodiments, the ferromagnetic element and the balloon form a nested structure.
According to still further features in the described preferred embodiments, the ferromagnetic element includes a telescopic element designed and configured to extend in the direction of the magnetic force.
According to still further features in the described preferred embodiments, a plurality of hollow openings is disposed on the catheter.
According to still further features in the described preferred embodiments, the catheter is designed and configured such that the first end of the catheter extends past a sphincter.
According to still further features in the described preferred embodiments, the device further includes: (c) a buoyant material operatively connected to the catheter, wherein the insert further includes a material the specific gravity thereof being less than the specific gravity of water, wherein the material allows the insert to be buoyant in aqueous fluids.
According to still further features in the described preferred embodiments, the buoyant material has a specific gravity of less than 1.0, such that the device is buoyant in urine.
According to still further features in the described preferred embodiments, the material is selected from the group consisting of foam, porous solid, liquid and gaseous materials.
According to still further features in the described preferred embodiments, the catheter has a plugged section, such that when the device is disposed within the body, a magnetic force applied to the ferromagnetic element causes the first end to be wedged into the urinary tract, thereby obstructing the passage of urine through the urinary tract.
According to still further features in the described preferred embodiments, the ferromagnetic element has a plugged section, such that when the device is disposed within the body, a magnetic force applied to the ferromagnetic element causes the first end to be wedged into the urinary tract, thereby obstructing the passage of urine through the urinary tract.
According to still further features in the described preferred embodiments, the balloon has a lumen, and the catheter is designed and configured to move longitudinally within the lumen.
According to still further features in the described preferred embodiments, the balloon is designed and configured such that a surface of the lumen moves longitudinally along with the catheter as the catheter is withdrawn or returned to an internal space of the lumen.
According to another aspect of the present invention there is provided a method of modulating the passage of urine from the urinary bladder through the urinary tract of a human body, the method including the steps of: (a) providing a device including: (i) a catheter, and (ii) a ferromagnetic element operatively connected to the catheter; (b) disposing the device internally within the urinary bladder, and (c) bringing a magnetic source in proximity to the urinary bladder, such that a portion of the device wedges open the urinary tract in a retrograde fashion.
According to another aspect of the present invention there is provided a method of inserting a bladder insert into a urinary bladder, the method including the steps of. (a) providing the bladder insert including: (i) a catheter, and (ii) a ferromagnetic element operatively connected to the catheter; (b) introducing the bladder insert into the urinary bladder using an insertion device, and (c) detaching the insertion device from the bladder insert.
According to further features in the described preferred embodiments, the bladder insert further includes a folded balloon operatively connected to the catheter, and the method further includes injecting fluid through a valve into the balloon prior to step (c).
According to still further features in the described preferred embodiments, the method further includes: (d) withdrawing the insertion device from the urethra.
According to still further features in the described preferred embodiments, the insertion device includes a ferromagnetic element.
According to still further features in the described preferred embodiments, the ferromagnetic element includes a magnetic element.
According to still further features in the described preferred embodiments, the bladder insert is inserted into the urinary bladder via a supra pubic body wall.
According to still further features in the described preferred embodiments, the injecting is performed while the balloon is free-floating in the urinary bladder.
According to another aspect of the present invention there is provided a method of for removing from a urinary bladder, a bladder insert having an inflated balloon, the method including the steps of: (a) introducing a bladder insert retrieving module into the urinary bladder via a urethra; (b) attaching the retrieving module to the bladder insert; (c) at least partially deflating the balloon, and (d) removing the bladder insert, via the urethra, by means of the retrieving module.
According to still further features in the described preferred embodiments, the deflating of the balloon is effected by piercing the balloon, preferably with a needle.
According to still further features in the described preferred embodiments, after the piercing of the balloon, a fluid in the balloon is withdrawn.